(220 days)
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
The insertion portion of the device has a bending mechanism and a flexible tube consisting of the bending portion and an operating portion with a knob to control the bending. A forceps channel runs through the operating portion to the tip for inserting surgical instruments. The insertion portion's tip, called the "Distal end," contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, and Light guide. The bending portion is controlled by knobs on the control portion/operation section. The flexible portion, between the bending and control portions, contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The control portion/operating section provides a grip and mechanical parts to operate the endoscopes, including a Forceps inlet. The Scope connector links the endoscopes to the light source and video processor.
The provided FDA 510(k) clearance letter and summary for the FUJIFILM Endoscope Models EC-860P/M, EC-860P/L, and EC-860S/L primarily focus on demonstrating substantial equivalence to predicate devices through bench testing and compliance with various consensus standards. It does not describe a clinical study in the traditional sense, where device performance is measured against specific acceptance criteria in a human subject population using metrics like sensitivity, specificity, or accuracy, often seen with AI or diagnostic imaging devices.
Instead, the submission relies on demonstrating that the new endoscope models meet established performance specifications and safety standards through non-clinical testing.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each item. Instead, it refers to the subject device meeting "performance specifications" or demonstrating "substantially equivalent in performance to the predicate devices" for various parameters.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Electrical safety compliance (ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC60601-1-6, IEC 60601-2-18) | Met standards |
| Biocompatibility compliance (ISO 10993-1, ISO 10993-5, ISO 10993-10) | Met standards; no new concerns for safety/efficacy. |
| Endoscope specific testing compliance (ISO 8600-1, ISO 8600-3, ISO 8600-4) | Met standards. |
| Software specific testing compliance (IEC 62304) | Met standards; validation performed. |
| Reprocessing Validation (Cleaning, Disinfection, Sterilization) | Performed in accordance with FDA guidance. |
| Optical Performance: | |
| - Field of view | Subject device met performance specifications. |
| - Resolution | Subject device met performance specifications; demonstrated substantial equivalence to predicate. |
| - Color reproducibility | Subject device met performance specifications. |
| - Uneven illumination | Subject device met performance specifications. |
| Mechanical/Operational Performance: | |
| - Diameter of forceps channel | Subject device met performance specifications. |
| - Bending capability | Subject device met performance specifications. |
| - Viewing direction | Subject device met performance specifications. |
| - Rate of suction | Subject device met performance specifications. |
| - Air volume | Subject device met performance specifications. |
| - Water volume | Subject device met performance specifications. |
| - Working length | Subject device met performance specifications. |
| - LG output | Subject device met performance specifications. |
| - Distal end diameter (for EC-860P/M) | Value is between predicate and reference devices, no safety/efficacy concern. |
| - Distal end diameter (for EC-860P/L) | Same as reference device, no safety/efficacy concern. |
| - Distal end diameter, flexible portion diameter, max diameter (for EC-860S/L) | Same as reference device, no safety/efficacy concern. |
| Materials | Differences in materials validated through biocompatibility testing; no new safety/efficacy concern. |
2. Sample size used for the test set and the data provenance
No human or patient test set is described. The "test set" consists of the physical endoscope models themselves, subjected to various bench tests and standard compliance evaluations. The data provenance is derived from these non-clinical tests performed by the manufacturer, rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert readers to establish ground truth for clinical performance. The "ground truth" for the non-clinical tests is established by the specifications and standards themselves, and verified by testing personnel.
4. Adjudication method for the test set
Not applicable. There is no expert adjudication process described for clinical interpretation. The compliance with standards and performance specifications is determined through objective measurements and validated test methods.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an endoscope, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned. The clearance is for the physical endoscope models.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no AI algorithm involved in this device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this submission, the "ground truth" is defined by:
- Consensus standards: e.g., electrical safety (ANSI/AAMI ES 60601-1), biocompatibility (ISO 10993-1), medical device software (IEC 62304), endoscope-specific standards (ISO 8600 series).
- Manufacturer's internal performance specifications: These are the benchmarks against which specific performance parameters (e.g., field of view, resolution, bending capability) are measured.
- Predicate device performance: The "bench testing data regarding 'Optical performance' demonstrated that the subject devices are substantially equivalent in performance to the predicate devices." This implies that the performance of the predicate devices serves as a comparative ground truth for equivalence.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is described.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.